AzTrials
AzTrials

Major Depressive DisorderPhase 4VIVRENCT04448431

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

A Phase 4 study testing Vortioxetine and Desvenlafaxine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 80 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Vortioxetine and Desvenlafaxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
80 sitesin 12 countries
Study dates
18 Jun 2020to 4 Feb 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • The patient has a MADRS total score ≥24 at screening and baseline.
  • The patient has had the current MDE for ≥3 months and < 12 months.
  • The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
  • The patient wants to switch antidepressant treatment.

Who cannot join

  • The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
  • Other in- and exclusion criteria may apply

Trial locations and contacts

80 sites in 12 countries.

80 sites in 12 countries

Russia15 sites
  • Arkhangelsk Regional Clinical Mental Hospital

    Arkhangelsk, 163530

  • GUZ Engels Psychiatric Hospital

    Engel's, 413124

  • Moscow Scientific Research Institute of Psychiatry

    Moscow, 107076

  • Clinic named after professor Yu. N. Kasatkin FGBOU DPO RMANPO Minzdrava Rossii

    Moscow, 125284

  • Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

    Nizhny Novgorod, 603155

  • Leningrad Regional Psychoneurological Dispensary

    Roshchino, Leningradskaya Oblast', 188820

  • Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

    Rostov-on-Don, 344022

  • LLC Medical Center Nova Vita

    Rostov-on-Don, 344082

  • St. Nicolas State Psychiatric Hospital

    Saint Petersburg, 190121

  • Hospital OrKli , LLC

    Saint Petersburg, 199178

  • LLC Astarta

    Saint Petersburg, 199226

  • Saratov State Medical University

    Saratov, 410028

  • State Budgetery Educational Institution Of Higher Professional Education Smolensk State Medical U...

    Smolensk, 214019

  • Region Specialized Psychiatric Hospital No.2

    Stavropol Region, Kochubeev District, 357034

  • Yaroslavl Regional Clinical Psychiatry Hospital

    Yaroslavl, 150003

Other trials in Russia

Argentina14 sites
  • Clinica Privada Banfield

    Banfield, Buenos Aires, B1828CKR

  • CINME (Centro de Investigaciones Metabolicas de Buenos Aires)

    Buenos Aires, C1056ABJ

  • Cenydet-Centro Neurobiologico Y De Estres Traumatico-Biopsychomedical Research Group Srl

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1058AAJ

  • Fundacion para el Estudio y Tratamiento de las enfermedades mentales FETEM

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1133AAH

  • INAPsi (Instituto Nacional de Psicopatologia)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BOA

  • Sanatorio Prof. Leon S. Morra S.A.

    Córdoba, Providencia de Cordo, X5009BIN

  • CEN (Centro Especializado Neurociencias)

    Córdoba, 5000

  • Instituto Modelo de Neurologia Fundacion Lennox

    Córdoba, X5000FAL

  • Instituto Medico DAMIC - Fundacion Rusculleda

    Córdoba, X5003DCE

  • Clinica Privada De Salud Mental Santa Teresa De Avila

    La Plata, Buenos Aires, 1900

  • Instituto De Neurociencias San Agustin SA

    La Plata, Buenos Aires, B1900BHE

  • Centro De Asistencia E Investigacion En Neurociencias CENAIN

    Mendoza, 5500

  • Resolution Psicopharmacology Research Institute

    Mendoza, M5500BCR

  • CIAP (Centro de Investigacion y Asistencia en Psiquiatria)

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Ukraine11 sites
  • CI of KRC Regional psychiatric and narcological medical association

    Hlevakha, 8631

  • Ivano-Frankivsk Oblast neuropsychiatric hospital No. 3

    Ivano-Frankivsk, 76014

  • Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional clinical psychiatric hosp...

    Kharkiv, Kharkivska, 61068

  • Academy of Medical Sciences of Ukraine - Institute of Neurology, Psychiatry and Narcology

    Kharkiv, 61068

  • SI INPN Namsu

    Kharkiv, 61068

  • Municipal Non-profit Enterprise Odesa Regional Psychiatric Hospital No.2 of Odesa Regional Council

    Kominternivskyy, Odesa Oblast, 67513

  • Lviv Regional State Clinical Psychiatric Hospital, Lviv Danylo Galytsky National Medical University

    Lviv, 79021

  • Odessa Regional Medical Centre of Mental Health

    Odesa, 65006

  • Ukrainian Medical Stomatological Academy, Chair Of Psychiatry, Narcology And Medical Psychology B...

    Poltava, 36006

  • Communal Non-commercial Enterprise Cherkasy regional psychiatric hospital of Cherkasy regional co...

    Smila, Cherkasy Oblast, 20708

  • Vinnitsa National Medical University

    Vinnitsa, 21005

Other trials in Ukraine

Czechia9 sites
  • Dr.Jan Holan MD, Office of

    Brno, 61500

  • Meditrine s.r.o. - Psychiatricka Ambulance, Lecebne Centrum

    Havířov, 73601

  • Clinline services s.r.o.

    Hostivice, 25301

  • Neuropsychiatrie HK, s.r.o.

    Hradec Králové, 50009

  • National Institute of Mental Health

    Klecany, 25067

  • Psychiatricka Ambulance

    Kutná Hora, 28401

  • A-Shine s.r.o.

    Pilsen, 31200

  • Clintrial s.r.o.

    Prague, Prague 10, 100 00

  • Institut neuropsychiatricke pece

    Prague, 18600

Other trials in Czechia

Bulgaria6 sites
  • MHAT Dr. Hristo Stambolski

    Kazanlak, 6100

  • UMHAT Sv. Ivan Rilski EAD

    Plovdiv, 4002

  • Center For Mental Health-Rousse

    Rousse, 7003

  • MC Complete Medical Solutions

    Samokov, 2000

  • Centre for Mental Health- Sofia

    Sofia, 1202

  • Diagnostic Consultative Center Mladost-M Varna OOD

    Varna, 9020

Other trials in Bulgaria

Slovakia6 sites
  • Psychiatricka ambulancia, MENTUM, s.r.o.

    Bratislava, 82007

  • Epamed, S.R.O

    Košice, 040 01

  • Psycholine S.R.O.

    Rimavská Sobota, 97901

  • Crystal Comfort, s.r.o.

    Vranov Nad Topou, 09301

  • BONA MEDIC s.r.o.

    Zlaté Moravce, 95301

  • Psychiatricka Ambulancia

    Zlaté Moravce, 95301

Other trials in Slovakia

Sweden5 sites
  • Affecta Psyikiatri AB

    Halmstad, 302 48

  • ProbarE i Lund

    Lund, 22222

  • Smaert & Psykiatricentrum Malmoe

    Malmö, Skåne County, 21137

  • ONE LIFETIME Lakarmottagning

    Skövde, 541 50

  • ProbarE

    Stockholm, 11329

Other trials in Sweden

Spain4 sites
  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08041

  • Centro De Salud Mental La Corredoria

    Oviedo, Principality of Asturias, 33011

  • Hospital Psiquiatric de Palma de Mallorca

    Palma de Mallorca, 07011

Other trials in Spain

Belgium3 sites
  • Algemeen Ziekenhuis St. Lucas-St. Jozef

    Bruges, 8310

  • SINAPS - University Antwerpe- Psychiatrisch Ziekenhuis Duffel

    Duffel, 2570

  • Cliniques De Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Latvia3 sites
  • Psihiatrijas Centrs

    Liepāja, Liepajas Rajons, 3401

  • Riga Centre Of Psychiatry And Addiction Disorders

    Riga, 1005

  • Sigulda Hospital Outpatient Clinic

    Sigulda, LV-2150

Other trials in Latvia

Mexico3 sites
  • Medical Care and Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, 03100

  • CRI Centro Regiomontano de Investigacion SC

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Estonia1 site
  • Marienthali Kliinik

    Tallinn, 11315

Other trials in Estonia

About this study

Official title: A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment

The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

Read the detailed description

The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.

At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

Being tested
Vortioxetine, Desvenlafaxine
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VortioxetineDrug

    10 or 20 mg/day, capsules, orally

  • DesvenlafaxineDrug

    50 mg/day capsules, orally

Study groups in NCT04448431
Study groupRoleWhat they receive
VortioxetineExperimental8 weeks treatment
Receives: Drug: Vortioxetine
DesvenlafaxineActive comparator8 weeks treatment
Receives: Drug: Desvenlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score

    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

    Measured: From baseline to Week 8

Secondary outcomes (15)
  1. Remission (defined as a MADRS total score =<10)

    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

    Measured: At Week 8

  2. Response (defined as a => 50% decrease from baseline in MADRS total score)

    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

    Measured: At Week 8

  3. Change in MADRS anhedonia factor score

    (based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))

    Measured: From baseline to Week 8

  4. Change in Digital Symbol Substitution Test (DSST) total score

    DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).

    Measured: From baseline to Week 8

  5. The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT)

    The EEfRT is a computerized task which measures reward motivation in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.

    Measured: From baseline to Week 8

  6. Change in Clinical Global Impression - Severity of Illness (CGI-S) score

    The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms.

    Measured: from baseline to Week 8

  7. Clinical Global Impression Scale- Global Improvement (CGI-I) score

    The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)

    Measured: at Day 7,28,56

  8. Change in Functioning Assessment Short Test (FAST) total score

    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time

    Measured: From baseline to Week 8

  9. Change in FAST sub-domain scores

    The FAST is a clinician-rated scale designed to assess difficulty in functioning. The FAST consists of 24 items in 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties.

    Measured: From baseline to Week 8

  10. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

  11. Change in Q-LES-Q work subscale

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

  12. Change in Q-LES-Q household duties subscale

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

  13. Change in Q-LES-Q school/course subscale

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

  14. Change in Q-LES-Q leisure time activities subscale

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

  15. Change in Q-LES-Q social relations subscale

    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

    Measured: From baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start18 Jun 2020
  3. Primary completion6 Jan 2022
  4. Study completion4 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448431
Sponsor's protocol ID
18498A
Acronym
VIVRE
Status last verified
Feb 2022
First submitted
23 Jun 2020
Last updated
14 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Gill H, McIntyre RS, Christensen MC. Analysis of reward behavior in patients with MDD and partial response to SSRI therapy treated with vortioxetine versus desvenlafaxine: Experience with the Effort-Expenditure for Rewards Task (EEfRT) in the VIVRE study. J Affect Disord. 2025 Nov 1;388:119563. doi: 10.1016/j.jad.2025.119563. Epub 2025 May 31.

    PubMed 40456468
  • McIntyre RS, Florea I, Pedersen MM, Christensen MC. Head-To-Head Comparison of Vortioxetine Versus Desvenlafaxine in Patients With Major Depressive Disorder With Partial Response to SSRI Therapy: Results of the VIVRE Study. J Clin Psychiatry. 2023 May 22;84(4):23m14780. doi: 10.4088/JCP.23m14780.

    PubMed 37227402

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vortioxetine and Desvenlafaxine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 80 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in Russia, Argentina, Ukraine, Czechia, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score (time frame: From baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448431, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in